Conventional electro-stimulation treatments for urinary and faecal incontinence require a patient to apply stimulation via an internal electrode in electrical contact with the body. Treatment is applied for periods ranging from 10 minutes to several hours each day.
A conventional electro-stimulation system includes pulse generator housed in a portable battery box and an electrode pad for attachment to the patient. Such systems are often used for the relief of chronic back pain or induced muscle contraction. These systems fall under the general classification of transcutaneous electrical nerve stimulation systems (TENS).
The above mentioned electro-stimulation systems conventionally use a drive signal to the electrode which is characterised by a sine wave, square wave, or spike impulse geometry, and is either monophasic, capacitively coupled monophasic, biphasic or asymmetric. Differing therapeutic effects are achieved using different drive signal types. Conventionally such stimulation systems allow for a variation of drive signal pulse width or frequency by the patient. However each such known portable stimulation system has electronics which are dedicated for providing a specific predetermined drive signal having a geometry and other characteristics matched to the intended therapeutic effect. Adjustment of the control signal is conventionally provided by electronic push switches and or rotational control knobs. Such switches and knobs cab often be tampered with by the patient, and it is thus difficult for a medical practitioner prescribing electrostimulation treatment to control the treatment when the patient is away from a clinic.
Other known electro-stimulators include microprocessor based units, but these have a problem that conventionally, specialised pre-programming equipment needs to be used at the clinic to set the signal parameters. Such equipment is expensive and often difficult to use.
Specific embodiments of the present invention aim to provide electrostimulation apparatus which can be adjusted and preset by a medical practitioner, medical assistant or clinician without requiring of them electronic or computer literacy, and once set is tamper proof by a patient.
In the treatment of incontinence, it is known to use a vaginal or rectal electrode comprising a molded plastic plug which is insertable into the body. Such plugs may be rigid, semi-rigid or of the expanding coil type. However, these known internal electrodes are uncomfortable and problematic due to their fixed size, difficulty to insert and poor contact with the body, producing uncomfortable sudden increases in pulse strength. Subsequently, patients dislike such treatments and compliance with the treatment is poor.
Surface electrodes of metal, metallised foil, carbonized rubber and other similar thin conductive plate materials are known. However, such materials are insufficiently flexible and can be problematic causing discomfort, soreness and subsequently poor compliance to treatment. The known surface electrodes are unsuitably shaped and sized, and insufficiently flexible for application over the perineal region adjacent to the vaginal and rectal tracts.
Prior art cloth electrodes are known from U.S. Pat. Nos. 5,038,796 and 4,708,149. These electrodes are designed for functional electrical stimulation (FES) and the symptomatic treatment of such afflictions as arthritic pain and back pain.
Pelvic Floor Exercises are a known treatment for exercising muscles which control the urinary function. Such exercises require levator ani muscles to be contracted and relaxed regularly during the course of a day or over a period of many weeks, often months.
A know aid for such exercises comprises a pre-formed core of rigid plastics material. Such aids are provided in a set of graded weights, requiring the (female) patient to insert them into a vaginal tract, and retain them in position. However, this is difficult for many patients, because commonly the smallest available weight available is too heavy, or the size is incorrect. Insertion and renewal of the cores can be problematic.
Another type of known device comprises a foam cushion, which is used to apply pressure at the bladder neck, keeping the bladder neck closed during normal movement and exercise. However, such devices are not intended for, and are unsuitable for performing Pelvic Floor Exercises. The devices must be softened with water prior to use.